Actively Recruiting

All Genders
NCT07030569

RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study

Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-06-22

500

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.

CONDITIONS

Official Title

RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with metastatic breast cancer who underwent a liver, lung, pleural, or bone biopsy in the metastatic setting between January 1, 2005 and January 1, 2024.
Not Eligible

You will not qualify if you...

  • No available imaging (CT scan and/or PET-FdG scan) within three months before the biopsy or before the last previous treatment interruption.
  • Unknown HER2 status.
  • Biopsy site is node, soft tissue, or other visceral locations not specified as liver, lung, pleural, or bone.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy, 20133

Actively Recruiting

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Research Team

C

Claudio Vernieri, MD, PhD

CONTACT

L

Leonardo Provenzano, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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